Hi, welcome, everybody. We're going to get started here in just a minute. This is Chris Romeo, the Senior Vice President of the Ventures team here at MedAxiom. We're just going to give everybody just a few more seconds to log on. We have a large group joining us today. And again, today's webinar is titled 2025 Updates on Billing and Reimbursement for CCTA and PLAC Analysis. This is going to be sponsored by our partners, Clearly. So let's just give it just a few more seconds. Okay, so as we've got people coming on board, let's just go through a few housekeeping items for today. I just want to let everybody know that this session is being recorded, and we'll be pushing this out to everyone for your viewing at another time. We'll be sending that through the Daily News. You can see that through the Academy. On today's presentation, the presentation itself will be made available in the chat button. So down below, you'll see a chat button. You can click on that, and there's a link to today's presentation. You can download that and share that with your colleagues or view that at a later time. We will be holding off on all questions until the end of the presentation, and we encourage you to submit all your questions through the Q&A button, which is also down at the bottom. So if you click on that, you'll be able to submit all of your questions there. So I think we're kind of ready to get started. So again, today's webinar is titled 2025 Updates on Billing and Reimbursement for CCTA and Plaque Analysis. I'd like to introduce Beth Hernandez, who's the Director of Reimbursement and Market Access for Clearly, and she's going to begin today's presentation and make the introduction. Beth, the floor is yours. Thank you. Good afternoon, everyone. Welcome to the 2025 Updates on Billing and Reimbursement for CCTA and Plaque Analysis webinar. We're joined today by three esteemed guests who will serve as our panel. First, allow me to introduce Dr. Jay Earls. Dr. Earls has served as a member of the Board of Directors for the International Society of Magnetic Resonance in Medicine, the North American Society of Cardiac Imaging, and the Society of Cardiovascular Computed Tomography. Additionally, he has authored over 200 articles, book chapters, abstracts, and other publications on advanced imaging technologies. Dr. Earls is currently a professor of radiology at George Washington University Hospital and continues to be a leader within the field of radiology in applications of advanced imaging technologies in cardiovascular care. Further, he currently serves as the Chief Medical Officer at Clearly Health. Next, allow me to introduce Dr. Ahmad Slim. Dr. Slim completed his internal medicine training at St. John's Hospital and Medical Center before volunteering to serve in the U.S. Army. There he completed his cardiovascular fellowship and advanced imaging training. While serving in the Army, the Department of Defense recognized his significant contributions to innovation with three military health system awards for his work in preventative cardiology, patient safety, and the most efficient radiation dose saving and cost-effective CT protocols. As an avid researcher, Dr. Slim has participated in numerous major clinical trials and has co-authored various books, peer-reviewed journal manuscripts, and teaching modules for the field of cardiology and cardiology specialty societies. As an expert in the field of cardiovascular imaging, he sits on the SCCT guidelines and membership committees and is the current Pulse Heart Institute Chief Medical Officer in Tacoma, Washington. And last, but certainly not least, we are joined by Ms. Alyssa Foster. Alyssa has worked in reimbursement for over 17 years. She co-founded Forefront Strategic Partners in 2020, which provides healthcare reimbursement expertise and consulting services. As a certified professional coder, and more specifically as a COC, Alyssa has extensive experience in billing and coding, as well as navigating the nuances of new code applications and CMS governance rulings. We're delighted to have each of you join us today. Welcome everyone. Without further ado, Dr. Jay Earls. Thank you, Beth, so much for that kind introduction and good morning or good afternoon, everybody. Thank you for participating in our webinar today. Before we have our reimbursement experts talk, I'm going to just give a little bit of overview on what clearly plaque analysis and further other analysis currently does. You know, we effectively assess the entire epicardial atherosclerotic plaque burden by quantifying and characterizing the plaque that's there. We also utilize that data to make a determination as to whether there may be FFR positive ischemia present. We use quantitative measures of atherosclerosis and stenosis from the datasets that we ingest. We inform patients' eligibility for care pathways, such as invasive angiography, and really provide easy-to-understand outputs based on both our plaque and stenosis data, as you can see. We have excellent clinical data that supports the veracity of our outputs. We've compared our outputs to invasive FFR imaging, multiple studies looking at quantitative coronary angiography, and then we have switched to intravascular imaging, looking at IVAS, near-field infrared spectroscopy, which specifically looks at the most dangerous of plaques, the low attenuation plaques, and we're currently wrapping up a large series of patients who have had optical coherence tomography at our core lab at Yale, and we're hopefully publishing those results in the near future. But overall, from an end-to-end standpoint, we have seven different machine-learned algorithms that can be used, and they automatically or semi-automatically identify all of the plaque, all of the stenosis that's present, look at the vascular morphology. It's very convenient. Our outputs are fully interactive in both three-dimensional and two-dimensional analyses. We also allow the users to make their own edits if they want to change any of the outputs that we get, and we develop curated patient-vessel segment and lesion-level quantification for the entire coronary tree. We also have our novel ischemia tool, which leverages our plaque outputs. Here you can see in this right coronary artery, the clearly stenosis and plaque product has identified four coronary lesions. When the ischemia algorithm was run, it has predicted that it would be positive for FFR in the invasive setting if that was done. It also goes through and looks at each of these four plaques and gives you very detailed information, percent diameter stenosis, the length of each plaque, the minimum luminal diameter. Then it goes into plaque characteristics as well as a reference volume, and it does that for every single plaque in each vessel so that really, before somebody takes a patient to the lab, they both have an understanding of whether ischemia will be there and if it is, exactly what each of the plaques look like to help plan revascularization. So really, we offer you a comprehensive view of all of the plaque and stenosis that's currently there. But of course, we can't do it without reimbursement, so let's go back to the experts and see how we can acquire that. Thank you, Jay. Dr. Slim, thank you for joining. Thank you, Beth. Thank you all for coming, and good morning, good afternoon, depending on what time zone you're at. And thank you, Beth, for the kind introduction. Next slide. When we talk about payment and policies, there are so many different variables that we have to balance out. We deal with a constant budget, growing population, getting older, and we have to balance our consumer, which is the patient, and the clinical benefit, both short and long term, coupled with payers, government, cost of care that's increasing, while reimbursement that's shrinking, somehow on a fulcrum of guidelines and healthcare policies. So there are a lot of variables that plays a role, and unfortunately, as we go through medical school, residency and training, no one spends the time to explain how is all this stuff balanced out and how do we get reimbursed for the services rendered. So the intent today is, as much as possible, try to demystify and clarify some of the work that we're talking about. Next slide. So you're going to hear different terminologies throughout your career, and these terminologies, for us, sounds interchangeable, but unfortunately, they are not. So when we talk about a payer, let's say CMS, policies, think of them as guidelines that applies across the board. But the fact that there are guidelines and policies does not mean in a specific region that you reside. This translates into coverage. The coverage is what's determined by the specific region or MAC in the case of CMS. So think of it as a guideline that recommends and the coverage helps determine how that procedure is paid for. And this is where the coverage determination administrator says, these are the criteria that we're going to set to get paid for that specific procedure. So how do we get paid for it? There is a healthcare coding alphanumeric code or Category 1 code from the CPT panel that we all utilize, that for us to get paid, we need to utilize that code. We need to meet the requirement for the coverage that's set by the administrator, and a certain set payment has to be assigned for it. And all components has to be met for us to get reimbursed for that payment. So as you can tell, just because there is coverage does not mean there is payment or reimbursement unless we meet all the criteria set by that MAC. Next slide. So how do we get the codes? I went through residency and fellowship and I never got any training or understanding. And I always thought it was just handed from the sky by someone because no one spent the time to explain how the process happens or who actually does it. The codes that we utilize or the CPT codes or the current procedural terminology codes, they're set by that committee under the umbrella of the American Medical Association. So the process is driven by the American Medical Association. The code that we utilize day-to-day for procedures that we do day-to-day is called the Category 1 code or permanent code. And there are three components to it when you look at it. There is the global component. So if you work within a system as a hospital-employed physician, for example, the hospital will bill for the global code and then internally divide it based on the allocations done for the professional component that's already preset by Medicare and the technical component that they retain. If you were in a private practice, you bill for the professional component, which is the work RVU that relates to you, and the system bills for the technical component. So for the majority, that's the structure of a Category 1 code. But how do we get there? Let's say that we have a new technology that comes along and that technology hasn't had significant research or backing for it. So as the newer technology is developed and as the research is being built and as they approach towards FDA approval, the payment for it, because there is no physician component, is not set by the AMA-CPT panel, but rather is built through a pass-through code by CMS called HEXPECS or Healthcare Common Procedure Coding. There is a negotiated rate, and that's what it gets paid for. Once we get to a point where there is FDA approval and there is research enough to support it, then we can go to the AMA panel and request a Category 3 code or a temporary code that allows us to track it and identify when do we reach a point that we can take it to Category 1 code. So why do we need that? Because there are two mandates for us to get Category 1 codes by the CPT panel. One is widespread utilization and B, research. So the HEXPECS and the FDA approval allows us to get to the point where there is research, and the Category 3 allows us to track the modality so we're able to identify widespread utilization. Now widespread utilization varies from one society to the next and one disease pattern to the next. As you would expect, due to the prevalence of cardiovascular disease, the bar is really high for widespread utilization when it comes for cardiovascular conditions. So you might see a code in the cardiovascular realm, lingers in a Category 3 format for about a year and sometimes three, just to be able to pass the threshold of widespread utilization. Once both are met, now we can go back to the AMA panels, the CPT panel and the AMA and request the formation of a new Category 1 code that we all use in our day-to-day operation. Now you would think we're done, but unfortunately we're not. It takes about a year from the approval of a Category 1 for it to be published and fully utilized. And the reason behind it is the next step after going through the CPT panel is to go to what we call the RUC panel under the AMA. Next slide. And the RUC committee is the Resource-Based Relative Value Scale Update Committee. It's a mouthful, and that's why a lot of us just refer to it as the RUC committee. Their job is to help us determine the assigned RVU for a procedure that we're utilizing today. The professional component, believe it or not, we always believe that it's not determined or help determined by us. But in reality, it is. It's based off of a survey that is sent to providers across the United States in varying environment. And that survey have different modalities to compare to and allocated time. And based on the survey done by these providers, the allocation for time goes back to the RUC committee who makes determination based on that feedback and these surveys of what time allocation it will be and what work RVU should be assigned to that work list. So we are actually a significant component in that determination unknowingly. And as far as the technical component goes, there are various items that goes in that determination, whether it's a charge master in the hospital, whether it's the invoice, and then determination is based off of an average of everything. Next slide. And again, we're not done. The RUC committee advises CMS. It gives a recommendation to CMS who analyzes the data, analyzes the surveys and the charges and makes final determination and a decision, and then publishes towards the end of the year, the assigned RVUs to the professional component, the technical component and a global component. So that is how we really get the codes that we utilize day to day to be able to get reimbursed for the services rendered. And that's the process that it follows to get to that final destination. Next slide. And of course the process repeats itself. And that's why the committees meet on regular basis on a quarterly basis because as you believe it or not, there's tons of codes that are coming through from every society for every procedure that we do. Next slide. So, when we talk about cardiac CT, because of the budget neutrality, there's always anticipated budget cuts that comes every year that affect the conversion ratio by which we get reimbursed. Keep in understanding, there are two payment methodologies done by Medicare when we look at distribution of payment. One is the physician fee schedule, and that's in the physician outpatient setting, as opposed to OPPS, or outpatient prospective payment, and that's in a facility-based payment. The coverage criteria, the restrictions, they vary based on local coverage determination done by the MAC, or Medicare Administrative Contractor. Like I said, these are different regions, and they have different criteria for payment that we have to meet to get reimbursed. But cardiac CT is a perfect example. That is a very well-known Category 1 code. The global code is a 75574, the 26 modifier is our professional component as providers, and the TC is a technical component. There was about 2 to 4% reduction in payment in 2024 that was published, but this is the first year that we actually garnered an increase in the payment for 75574 by about 104%. And that's just based on a lot of work that we did in SCCT from advocacy effort to make CMS understand that this is a cardiovascular test with significant requirements, and it got moved to a different ambulatory patient reimbursement unit that allowed us to increase it and account for all the work that goes in it. So that was a significant success for the society and for our patients. Next slide. When we talk about PLAC or AIQCT or ICPA, it is a Category 3 code right now, but it got approved for Category 1, and it's going through the process of evaluation and valuation through the RUC and eventually CMS, so the same process that we talked about. With the MAX, the way that it is approved for payment is acute or stable chest pain with no known CAD that's eligible for CTA, and CAD-RADS 1, 2, or 3 or intermediate risk, and cardiac evaluation is negative or inconclusive for ACS. When we're dealing with Category 3 codes, there are a lot of times where the MAC sometimes mixes the test that we're doing along with the parent code that we're working with, in this case, CTA. So to ensure that the right patient gets the right test, they put restrictions on who is covered, and these restrictions are manifesting in what you see here with the intent of eliminating patients with known ACS or suspected ACS and patients who are asymptomatic and patients that are heading for an intervention in the form of CAD-RADS 4 or patients with no diseases in CAD-RADS 0. Next slide. And the list of restrictions goes on to include, again, we talked about screening patients without symptoms, whether there's contraindications for CCTA, of course, if you don't get a CCTA, you're not going to get PLAC, in conjunction with invasive coronary interventions, patients with CAD-RADS 0, and of course, MI within 30 days, kind of goes without saying to the list of restrictions that we highlighted earlier. Next slide. So this is the current codes that are being utilized for tracking. The global code is 0623T, and that will cover everything. But because it's a tracking code, we have it divided into three components, 624 is for the site data transmission and the work that goes into it, 625 for the technical component that covers the services of CLEARLY and other vendors, and 626 is a professional component. Just because it's a tracking code does not mean it's not an unpaid code, it's actually a paid code through contract negotiation based on the site that you're in. It's when you become a Category 1 code that gets solidified through the process for trackable payment. It has to be linked to R93.1 for CMS payment as the ICD-10 to utilize, and that's not necessarily unique to PLAC. The same thing applies for CTFFR as the primary code that they like to see linked to it. In 2025, the Medicare Physician Fee Schedule is carrier-priced versus OPPS, it's set under APC 1511 at 9.50 and 50 cents. And in 2026, as I mentioned earlier, right now it's gone through the RAC evaluation that advises CMS and we anticipate January 1, 2026 to have detailed published Category 1 code. Next slide. And we wanted just to touch a little bit on the FFR-CT component. Just the fact that you utilize PLAC, it's not mutually exclusive to the utility of the FFR or the ischemia component. These are two separate codes and they could be built on the same imaging modalities. Criteria and restrictions varies between MACs, it's a Category 1 code. Under Physician Fee Schedule, the 75580 is the global code. The technical one is 805 and the 3364 is the professional component that was set by the most recent survey that was done for the physicians and advised for to CMS. And under OPPS, the global code is higher, as you would expect, at 1017, with actual 2% increase as opposed to 2024. Again, and most of the time it needs to be linked to that specific ICD-10. And these are two different examples that you could utilize in the form of Category 3 and Category 1. Hopefully this was useful and informative as to the process that we follow to be able to get us from HEC specs to Category 3 to Category 1, and hopefully help demystify some of the terminologies that we never get significant amount of education on. Next slide. And this is the conclusion. Thank you all for your time. Thank you so much, Dr. Slim. We'll now turn it over to Alyssa Foster. Alyssa? Perfect. Thank you, Beth. And thank you, Dr. Slim. I think the next slides build really well on top of the incredible detail that you just provided. Next slide. So, I just wanted to dive into a little more detail in terms of what happens now that the AMA CPT Editorial Panel has approved the new CPT codes for the clearly analysis for plaque. As Dr. Slim mentioned, these codes will become effective and reportable on January 1, 2026. So again, as Dr. Slim mentioned, the codes were approved very recently by the AMA CPT. This occurred at the October 2024 CPT Editorial Panel meeting. Since then, these codes have gone through the RUC process to be valued and make recommendations to CMS regarding the RVUs, which ultimately determine the payment for these new codes. The RUC meeting actually just occurred last week, and unfortunately, their discussions are confidential. But soon in the spring, CMS will be evaluating those recommendations and determining whether or not to accept the recommendations and publish in the proposed ruling early in the summer what the RVUs will, again, propose to be for the new codes. And that leaves us with about a 60-day comment period where any interested stakeholder has the ability to react to CMS's preliminary proposed RVUs for the new CPT codes. So I would also urge if you're supportive of the RVUs and the potential payment to support that. If they're unsatisfactory, we'll see some comments come in explaining why those may or may not be satisfactory. And all of the comments that are received are taken into consideration by CMS, and they will publish the final RVUs and the final payment for the new codes in early November in the final rule. And then again, as I mentioned, the new codes and those payment rates from Medicare become effective on January 1st. So a lot's happening this year to prepare for those codes to become effective and usable. Perfect. So to talk about coding and payment, let's talk a little bit about what happens in terms of coverage, again, building on what Dr. Slim mentioned previously. So payers are already aware of the decisions that have been made by AMA CPT and that there are new codes coming. And so what happens is that they will be preparing their claims processing systems to be able to accept claims with those new codes in January. Same goes with the payments that are published as well. If they use Medicare payment, if commercial payers use Medicare payment as a reference for their contracting and payment rates that they set as well. This also may mean that payers who either currently cover clearly analysis for plaque or do not yet cover may be reevaluating their internal coverage decisions. We feel optimistic that if payers are currently covering the clearly analysis, you know, getting a new permanent Category 1 CPT code is certainly another feather in the cap. So we expect them to continue to cover clearly. But we might also see that payers who haven't made any coverage determinations or cover but are essentially silent on the policy side decide that the Category 1 CPT code implementation triggers a positive coverage decision. Certainly there's always the chance for a negative outcome in any policy review. But again, having a Category 1 CPT code does signal to the payer community that certain criteria has been met, which is a positive advantage. So again, the majority of the change in any decisions that exist today, we anticipate to be positive. Next slide. Perfect. So again, just to reiterate some information that Dr. Slim shared regarding Medicare coverage. So we see here on the map, the light green indicates the Medicare Administrative Contractors or MACs that have recently published positive local coverage determinations for the clearly analysis for plaque. You can see this is quite a large percentage of the geography. And on the left side is the coverage criteria that is outlined in those MACs positive LCDs. So again, just to reiterate, the coverage criteria states that the analysis is reasonable and necessary when the patient has acute or stable chest pain with no known CAD and is eligible for CCTA. In addition to that, it's an and, not an or, the CCTA must classify the patient as either immediate risk or CAD RADS 1, CAD RADS 2, CAD RADS 3, in terms of the category in the CCTA, and the cardiac evaluation is negative or inconclusive with ACS. And of course, probably logically makes sense to the audience, the clearly analysis should not be performed until the CCTA has been completed and interpreted, again, to justify medical necessity for the analysis. Next slide, please. One thing I wanted to mention on the previous slide, so those gray states that are linked to the MAC jurisdictions that don't have the positive coverage determinations yet, does not mean that there is negative coverage. It just means that those MACs have not yet published the LCD similar to the MACs that have published the LCD. We refer to these MACs essentially as being silent, again, since there's no published LCD. But then next slide, what they have done is published documentation requirements that they would like to see for the clearly analysis cases in order to consider coverage for the analysis. Really important that if you are doing the clearly analysis and you are aligned to one of those grayed out jurisdictions, that when documenting medical necessity for the analysis, you're properly reporting the history and physical examination, probably already doing that anyway, lab and diagnostic test results, if you have them, again, any progress notes, office notes to justify medical necessity for the service performed, operative or procedure report, any full text peer review articles to support, again, the use of the analysis, societal guidelines, and any other supporting documentation, again, to justify medical necessity for performing the analysis. And you're more than welcome to, you'll have access to this presentation, I believe. Look at the different Medicare administrative contractors' guidelines to have this as a reference as well. But again, what you see here on the screen shouldn't be terribly surprising. Again, in a nutshell, these, I think, eight bullets really are just the MAC reinforcing to the provider that it's important to document medical necessity for the analysis. Perfect. Let's move on to the next slide. Okay, so I just wanted to cover some best practices for when claims don't go through smoothly and there are some coverage issues. This could apply to really any technology, but also specifically to the clearly analysis. So again, we've talked about it already. It's really important to document medical necessity. And if the claim is denied, to then provide that documentation to the insurer to explain and justify why the analysis was needed to appropriately treat the patient. We really encourage that if you are appealing a denial for a payer that has alignment to one of the Medicare administrative contractors who recently published the positive coverage guidelines for the analysis to let them know that Medicare covers this test under these circumstances. And the hope is that that positive coverage from Medicare can help leverage commercial payers or other payer types to follow Medicare's lead and also cover the analysis. Because they might not be aware that it exists or if they are aware, maybe they just need a little push in the right direction. Also very helpful to include the published clinical evidence supporting use of the test. An additional helpful piece of information for payers is to leverage the positive decision from the AMA CPT editorial panel regarding the new codes. Again, that will be implemented in January. As Dr. Slim mentioned, there's a relatively high bar for the panel to make the decision to convert a Category 3 code to a Category 1 code. This decision from the panel in October, again, that will be implemented in January, signals to payers that the evidence and utilization for the Clerly analysis has met that bar and therefore, again, something to consider when making coverage determinations as well. In the case where maybe a Level 1 or 2 appeal is denied or if the payer allows the provider to participate in a peer-to-peer discussion with the payer, we do highly recommend that step. I actually got my start in reimbursement by working in a call center at United Healthcare. I know full well that sometimes the people who are reviewing claims, who are reviewing denials, don't necessarily have the medical and clinical expertise to make the most appropriate decision regarding coverage. A peer-to-peer is actually a discussion from you, the provider, with another medical director who has a much higher understanding and specialty knowledge so that a truly informed clinical decision or clinical conversation can take place about the patient-specific case. In a lot of cases, we see a higher level of success when that peer-to-peer discussion is able to happen versus submitting appeals to, again, probably a lower-level person without a medical background and reviewing denials and appeals. And last but not least, I do want to acknowledge that appeals can be time-consuming. We understand providers are busy and doing more paperwork is not ideal, however, it is actually a leveraged strategy to push payers to acknowledge, again, the evidence and medical necessity for this test and can really help enforce change in coverage policies at multiple levels. And I can attest that the appeals process was kind of one of CLEARLY's really important strategies to help them get the coverage they have today and support the amazing coverage team at CLEARLY, who have been able to leverage some of that with payers. And I just have to acknowledge the CLEARLY team. I've been in this industry for a while now, and they have accomplished quite a lot in a very short period of time because they've thought about this really intelligently and tactfully and good things to come in 2026. Next slide. I think that concludes my slides. Thank you so much. Thank you so much, Alyssa. Chris, we'll turn it back over to you now for Q&A. Thank you very much. We've got a large group that's on the call. So if you can, please submit any questions that you have via the Q&A button on the bottom of your screen. We've already had a few questions that have been submitted. So let's get started. First question I've got here is eligibility for CCTA is wide, but there's only one ICD-10 code for AI QCT coverage. What is the definition of abnormal findings? Yeah, I'm happy to take that, Chris. So the ICD-10 code that we're referring to here is the R93.1, I believe Dr. Slim mentioned that earlier. The descriptor is abnormal findings on diagnostic imaging of heart and coronary circulation. This is the only ICD-10 code that CMS has listed in terms of supporting positive coverage. And as I read the descriptor, you can see that it's a little bit vague. So it is really important, again, as I mentioned a little bit earlier, to document the abnormal findings that, again, support medical necessity. But also to please also report any additional ICD-10 codes that would support medical necessity or that can describe the patient's condition. Don't want to tell you how to code or not to code and make sure you include those as well. In terms of what classifies as abnormal findings, again, the code is very, very general. So I don't know if one of the physicians want to speak to what abnormal findings look like. But, again, from a coding perspective and what would be required for coverage, it's that single code, which, again, the descriptor is relatively general. Okay. Thank you. I've got another question that's come in. Stable or unstable chest pain? Does this require additional evaluation to make sure the codes are included so they can go through Medicare? Chris, this is Jay. I'm happy to take that one. And the answer is no, actually. The Medicare is specific in their coverage stating that only R93.1 is the covered diagnostic code. Therefore, the patient must meet the description of that code, which is abnormal findings on diagnostic imaging of heart and coronary circulation. So fairly generalized, although the coverage policy, of course, does have specific requirements that CADRADS 1 through 3, et cetera. Additional codes can be added to the diagnosis. However, R93.1 most likely will need to be the primary code that's listed. Okay. Another question here submitted by a member. CMS says coverage for AI plaque analysis is not considered reasonable or necessary for disease surveillance. Does this mean follow-up CCTAs to measure disease changes would not be covered? I believe I can take this one as well, Chris. So there's actually no global period assigned to the existing Category 3 CPT codes. Again, as Dr. Slib presented, in the range 0623T to 0626T, therefore, there should not be restrictions in billing a follow-up CCTA. Definitely would also make sure that the group is aware that if you have coverage questions, whether they're specific or broad, you always have the opportunity to reach out to your local administrative contractor to get clarification of the policies that exist. So if you're still uncertain or want more clarification, you can always reach out to the MAC directly and provide additional details, and they'll tell you if it's covered or not. Okay. Thank you. What do I need to include in my report to be reimbursed by Medicare for AI QCT? Do I need to describe every coronary artery, total plaque volume? Question mark. I can take this one. As we mentioned in a couple of the slides that we highlighted, there are requirements that comes with coverage, and some of these requirements include history and physical and information as it relates to stable or acute chest pain, the performance of the CCTA and the quantification of disease, along with the CLEARLY or the plaque analysis report to include the plaque composition, and a lot of this stuff will be highlighted in the description of work when the Category 1 code is published and identified. But for now, these are the requirements by Medicare. Some of it could be in the existing history and physical exam that are performed that led to the CCTA and the description of the CCTA that eventually culminates in the plaque analysis. Okay. Thank you. Okay. Thank you. Another question, can a Medicare-eligible person pay privately if they don't meet criteria and have had CAC? I assume the clinic would pay for the CLEARLY, and the patient pays the clinic? Alyssa, would you like to take that question? Sure. So, yes, it's possible. There are, I think, some practice management practices that should be considered whenever you're engaging with a patient in terms of self-pay. But yes, as long as you're not also submitting a claim to Medicare and you're only engaging with the patient with a self-pay relationship, then that would describe the process. Thank you. Are you saying that until the new code becomes effective January 1, to build a temporary codes and they are considered payment in addition to being tracking codes? I can take that as well. So, yes, until the new codes become effective in January, the existing Category 3 codes are the appropriate codes to bill. And as Dr. Slim mentioned, just because they are, quote-unquote, tracking codes today does not mean they are not eligible for payment. There's just no national payment rate yet established, so payment will depend on who you're billing to and what the payment has been set locally or by your contract if it's a private or commercial payer that you're billing to. And as we mentioned, from a coverage perspective, the majority of MACs now do cover, and those grayed-out MACs, while they haven't published coverage LCDs, they haven't said that they won't cover it. So, on the commercial side, it really is going to vary depending on the insurer you're billing to if there's coverage or not. And if I can add one thing to Alyssa's response there as well, you mentioned the five MACs that have current LCDs. The two MACs, First Coast and Novitas, that do not have LCDs in place, do have payment assigned on the physician fee schedule for clearly plaque analysis. Good point, Beth. Another question, is there a minimum or maximum time for the documented HMP to support determination? Alyssa, would you like to take that one as well? Yeah, so documentation should generally occur very, very quickly after the, or as the service is being provided. The reason that doing it quickly is because if the payer were to come back and ask to see that documentation to justify medical necessity to pay the claim, or even if the claim was paid and there's a retroactive claim review, you want to have that documentation ready and available. But in terms of a certain timeframe, I'm not aware of necessarily a time restriction unless that's covered uniquely in your provider contract. I was just going to add one more thing there is depending on the MAC, there are some regions where, for example, CTFFR has to be performed within a certain window from the original CCTA. So, you have to really look at the MAC and the LCD to help you determine some of these components. And we have another question. Does the initial claim need all the information bulleted in your presentation or only post denial redetermination? I can take that one as well. Again, depending on the payer, if you are able to submit information proactively with the claim, that is ideal because then if the payer requires it, they don't have to go back and ask for it. However, understanding that that is an additional step, additional paperwork, and may cause claim delays. I know some practices, and this is not even specialty specific, will go ahead and submit the claim without required documentation and then wait for a denial or like an additional documentation request to send that in. So, I think it just depends on the practice and kind of your internal processes. But being proactive is going to result in less denials in general. Thank you. How does reimbursement for CT coronary with CT FFR and plaque analysis compare to reimbursement diagnostic cath? Dr. Slim, would you like to address that question? There are two different procedures in two different APCs. So, the assignment for diagnostic cath is, and again, depends which format we're talking about. But when you're talking about cath, you're talking about OPPS. And the payment for it fell under a collective of APC where it was valued, of course, at a higher level. When the CCTA initially was being evaluated, it fell under the APC for all radiological CT scans, and that led to significantly lower reimbursement because it got averaged with services that does not require significant services that comes with it, whether it's the EKG gating, the medications, the monitoring, the gating, the acquisition, the restructure, the construction. So, there's so many different layers. As it moved to a different APC under the cardiovascular realm, we were able to account for a lot of these services, and now it's getting averaged with cardiovascular imaging. Now, it's not the same APC as cardiac cath, as invasive procedure, but it is within the cardiovascular realm for ischemia evaluation, and that's why it got the 104% bump in payment. Hopefully, this answers the question. Another question, can R93.1 be coded and reported on the claim if the patient has a related definitive diagnosis established by the physician? And I can take that one also, Chris. The answer is yes, absolutely. There's, I think, 19 spaces on the claim form for diagnosis coding, so absolutely, you should code any additional diagnoses that are identified. Just make sure you're also including the abnormal findings, ICD-10, the R93.1. Okay, that's all the questions. Well, I take that back. Based off available reimbursement information known, it seems there would not be many circumstances where plaque analysis coding could be appropriate, but ischemia coding would not be appropriate. Do I understand this correctly? Wait. The plaque analysis coding would be appropriate, but ischemia coding would not be appropriate. Alyssa, do you want to take that or would you like me to answer it? Yeah, go ahead, Beth. Yeah. So, actually, plaque analysis is done pretty frequently throughout the U.S. right now and is continuing to grow. The way that it is coded right now is in the office with 0623T and in the facility, depending on the work that's being performed, with 0624T through 0626T. After the plaque analysis is done, there may be times when the patient needs to also have the ischemia analysis performed, and at that point, you would bill the 75580. So, yes, you could absolutely do plaque on its own or do plaque in ischemia as well. Jay, do you have anything to elaborate on that particular question? Yeah, no, I would agree. There's a little bit of overlap between the two. You know, when the stenosis is low, it would only be appropriate for plaque analysis. When the stenosis grade is high, which would be a CAD-RADS 3 or 4, the plaque analysis is not covered, but ischemia would be covered in that range. And then between the two, there is some overlap. So, certainly, there are situations where plaque analysis is appropriate, situations where ischemia analysis is appropriate, and in the middle, there are some overlap in which both may be appropriate, depending on the clinical scenario. Very good. We have no other questions at the moment, so I'd like to thank, clearly, for this presentation. I'd like to thank the panelists. Dr. Earls or Beth, would you have any closing comments for our members? I'll turn it over to Jay, and then I'll close us out. No, we thank you. You know, this plaque analysis has been growing very rapidly. We here clearly do believe that this is the way that we will handle coronary disease in the future. We have many sites that have incorporated it into their workflow. We're very excited that Medicare has decided to cover it in all of the MACs in one form or another, as we discussed, and we believe that as we go to the Category 1 code as of January next year, we will have increasing commercial insurance so that, you know, I think all of these payers have recognized or will be recognizing that this is a very important advancement in coronary artery disease care, and we think that we will be helping many, many people with this new technology going forward, as we discussed. Beth? Yes, thank you so much, Dr. Earls. Everyone, thank you so much for joining this call. If you have any additional questions, please feel free to reach out to the Clearly team at clearlyhealth.com. You are more than welcome to ask us any questions. We are here to support you and your patients, and really our desire is to eradicate heart disease throughout the U.S. and the world, so you are part of that equation, and we thank you for your commitment to Clearly and to your patients, and again, thank you for your time and the speakers as well. And as a reminder, we have recorded this, and we will be pushing this out to the membership, so please take a look for that, but we do want to once again thank Clearly for their sponsorship of this great webinar. So with that, we'll close, but thank you very much. Have a great day. Thanks, Chris.

cardiac computed tomography angiography

CCTA

plaque analysis

MedAxiom

Category 1 codes

Medicare reimbursement

CPT codes

medical necessity

billing practices